JOURNAL OF SHANGHAI JIAOTONG UNIVERSITY (MEDICAL SCIENCE) ›› 2020, Vol. 40 ›› Issue (10): 1430-1436.doi: 10.3969/j.issn.1674-8115.2020.10.023

• Original article (Public health) • Previous Articles    

Construction of quality evaluation system of experimental investigator-initiated trial

SHI Wen-tao1, WU Si-cheng1, CUI Dong-qi1, CHEN Ling-yan1, CHEN Shi-jie1, WANG Bu-yi1, LIN Xiao-han1, ZHANG Liang1, QU Yi-hui1, XU Feng2#, WU Hao3, 4#   

  1. 1. Clinical Research Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 2. Department of Discipline Planning, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 3. Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 4. Institute of Otology, Shanghai Jiao Tong University School of Medicine; Shanghai Key Laboratory of Translational Medicine on Ear and Nose Diseases, Shanghai 200125, China
  • Online:2020-10-28 Published:2020-11-27
  • Supported by:
    Management Research Project of Shanghai Shenkang Hospital Development Center (2018SKMR-08); Clinical Management Optimization Project of Shanghai Shenkang Hospital Development Center (SHDC12017628); Project of China Hospital Development Institute, Shanghai Jiao Tong University (CHDI-2019-A-02).

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Abstract: Objective · To construct a quality evaluation system of experimental investigator-initiated trial (EIIT), and provide reference for EIIT quality control. Methods · The original draft of EIIT quality evaluation system was determined through literature analysis and internal discussion of the research group. Thirty-five experts were consulted using the Delphi method and then the quality evaluation system was determined. Analytic Hierarchy Process (AHP) was used to calculate the weight of each index. Results · The effective recovery rates of three rounds of experts' consultation were 100%, 91.43%, and 91.43% respectively. The authoritative coefficient were 0.84, 0.91, and 0.89 respectively. After three rounds of experts' consultation, the average scores of all indexes were>3.50, the coefficient of variation of each index was<0.30, and Kendall coefficients of concordance (Kendall's W) were 0.177- 0.331 (P<0.01). Finally, an EIIT quality evaluation system with three first-class indexes, eighteen second-class indexes and seventy third-class indexes was constructed. There were three first-class indexes including start-up period, implementation period and summary period and their weight values were 0.310 8, 0.493 4, and 0.195 8 respectively. The weight values of the second-class indexes and the third-class indexes were determined at the same time. The consistency ratios of single-sort and overall sort of all indexes were<0.1, which shows good logical consistency. Conclusion · The EIIT quality evaluation system constructed in this research is highly scientific and reliable, with guiding significance for improving the quality of EIIT.

Key words: quality evaluation, index system, investigator initiated, experimental trial

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